# K091074: Aem Disposable Electrodes,Model ESO300 Series

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: Aug 17, 2009 after 125 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Model ES0300 series AEM Disposable Electrodes: named in the summary without a submission number

## Most influential descendants
- K191612: Encision AEM Monopolar Laparoscopic Instruments and Accessories (2020), 1 descendant of its own
- K122580: Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction Irrigation Electrodes Model ES077X Series (2012), 1 descendant of its own
- K201018: Encision AEM enTouch 2X Scissor (2020), 0 descendants of its own
- K131949: Aem Disposable Suction Irrigation Electrodes (2013), 0 descendants of its own

## Recalls of this device
- Jun 15, 2012 · Class II · Z-1951-2012: Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could
- Apr 5, 2010 · Not classified · Z-1540-2010: Electrosurgical electrode tip insulation may crack and break off during use.
- Apr 5, 2010 · Not classified · Z-1546-2010: Electrosurgical electrode tip insulation may crack and break off during use.
- Apr 5, 2010 · Not classified · Z-1541-2010: Electrosurgical electrode tip insulation may crack and break off during use.
- Apr 5, 2010 · Not classified · Z-1544-2010: Electrosurgical electrode tip insulation may crack and break off during use.
- Apr 5, 2010 · Not classified · Z-1542-2010: Electrosurgical electrode tip insulation may crack and break off during use.
- Apr 5, 2010 · Not classified · Z-1545-2010: Electrosurgical electrode tip insulation may crack and break off during use.
- Apr 5, 2010 · Not classified · Z-1539-2010: Electrosurgical electrode tip insulation may crack and break off during use.
- Apr 5, 2010 · Not classified · Z-1543-2010: Electrosurgical electrode tip insulation may crack and break off during use.

## Indications for use
AEM Disposable Electrodes and AEM Disposable Handpieces are electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The devices are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K091074
Methodology: https://510kreport.com/methodology